Medication Treatment for Opioid Use Disorder in Expectant Mothers
NCT ID: NCT03918850
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2020-07-21
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BUP-XR
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
BUP-SL
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Interventions
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Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. be 18-41 years of age
2. be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA \< 12 weeks and is not planning to terminate the pregnancy
3. have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)
4. meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD
5. be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits
6. be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS
7. be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)
8. be able to understand the study, and having understood, provide written informed consent in English
Exclusion Criteria
1. have a physiological dependence on alcohol or sedatives requiring medical detoxification
2. have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:
* Suicidal or homicidal ideation requiring immediate attention
* Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
3. have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
* aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
* serum creatinine greater than 1.5X upper limit of normal
* total bilirubin greater than 1.5X upper limit of normal
4. be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
5. be currently receiving methadone or naltrexone for the treatment of OUD;
6. be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed;
7. be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.
18 Years
41 Years
FEMALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
T. John Winhusen, PhD
OTHER
Responsible Party
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T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
Principal Investigators
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T. John Winhusen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Gateway Community Services
Jacksonville, Florida, United States
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, United States
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, United States
CODA, Inc.
Portland, Oregon, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, United States
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, United States
Marshall Health MARC Program
Huntington, West Virginia, United States
Countries
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References
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Cash E, Cochran G, Smid MC, Charles JE, Humiston G, Wei Y, Mauerman N, Carlston K, Broussard G, Sengpraseut B, Martin PR, Winhusen TJ. Overdose risk profiles in pregnancy: Latent class analysis of pregnant individuals with opioid use disorder. J Subst Use Addict Treat. 2025 Sep 25:209809. doi: 10.1016/j.josat.2025.209809. Online ahead of print.
Winhusen TJ, Kropp F, Greenfield SF, Krans EE, Lewis D, Martin PR, Gordon AJ, Davies TH, Wachman EM, Douaihy A, Parker K, Xin X, Jalali A, Lofwall MR. Trauma Prevalence and Its Association With Health-related Quality of Life in Pregnant Persons With Opioid Use Disorder. J Addict Med. 2025 Jan-Feb 01;19(1):20-25. doi: 10.1097/ADM.0000000000001366. Epub 2024 Aug 6.
Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2019-0429-1
Identifier Type: -
Identifier Source: org_study_id
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